Informed consent for schizophrenia research: what is an investigator (or IRB) to do?

Informed consent for schizophrenia research: what is an investigator (or IRB) to do?
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精神分裂症研究的知情同意:研究者(或 IRB)应该做什么?

DOI:
10.1002/bsl.695
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发表时间:
2006
影响因子:
1.4
通讯作者:
Palmer,BartonW
Palmer,BartonW
中科院分区:
法学3区
文献类型:
--
作者:
Palmer,BartonW

文献摘要

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决策能力(NBAC, 1998)。对这份报告的反应促使越来越多的人对精神分裂症和其他疾病的知情同意和决策能力进行实证研究。Dunn(2006)对这一实证文献的杰出评论中提出的一些关键点包括以下几点。(a)作为一个群体,精神分裂症患者在决策能力方面的表现往往不如健康的比较对象,特别是在对披露信息的理解方面。(b)群体内存在相当大的异质性,因此诊断显然不是断定一个人缺乏作出有意义同意的充分决定能力的不适当依据。(c)认知缺陷比精神病理的严重程度更能预测决策能力受损。(d)在发展评估决策能力的结构化工具方面已取得重大进展,但仍然需要进一步发展这类工具。(e)对披露信息的理解可以通过简单地加强同意过程来改善,例如披露、查询和重新解释的互动过程,和/或结构化地提出关键信息。正如邓恩所指出的,在对NBAC(1998)报告的其他批评中,人们普遍担心,报告中对“精神障碍”的唯一强调可能会进一步对精神疾病患者造成不恰当的污名化。鉴于上述发现,认为精神分裂症患者作为一个群体不能给予有意义的同意或需要特殊的保护是不恰当的。
Decisionmaking Capacity (NBAC, 1998). Reaction to this report catalyzed a growing body of empirical research on informed consent and decisional capacity in schizophrenia and other conditions. Some of the key points made in Dunn's (2006) outstanding review of this empirical literature include the following.(a) As a group, patients with schizophrenia tend to perform worse than healthy comparison subjects on measures of decisional capacity, particularly in terms of understanding of the disclosed information.(b) There is considerable within-group heterogeneity, such that diagnosis is clearly an inappropriate basis on which to conclude a person lacks adequate decisional capacity to give meaningful consent.(c) Cognitive deficits, more than severity of psychopathology, are the strongest predictors of impaired decisional capacity.(d) There have been substantial advances in the development of structured tools for assessment of decisional capacity, but further development of such tools is still needed.(e) Understanding of disclosed information may be improved through simple enhancements in the consent process, such as an interactive process of disclosure, query, and re-explanation, and/or structured presentation of key information.As Dunn notes, among other criticisms of the NBAC (1998) report, there has been general concern that the sole emphasis on" mental disorders" in the report risks further inappropriate stigmatization of those with psychiatric illness. In light of findings such as the above, it would be inappropriate to assume that those with schizophrenia, as a group, are incapable of giving meaningful consent or require unique protections.